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Life Threatening? No
Write-up: Information has been received from a physician concerning a 11 year old female patient with no known drug reactions/allergies who in 2008 at 12 years old, was vaccinated IM with all three doses of GARDASIL (lot # not reported). The patient "had a normal eye exam before GARDASIL treatment and after starting GARDASIL treatment a later eye exam within the same year reported optic neuritis" in 2008. The patient sought unknown medical attention. Lab diagnostics test magnetic resonance imaging performed, no results provided. At the time of reporting the patient''s optic neuritis did not improve. Follow-up information has been received from the physician concerning the 11 year old female student with exercise induced asthma who was vaccinated IM into the left arm with the first dose of GARDASIL (lot number 658558/1061U) on 25-AUG-2007, the second dose (lot number 658563/1063U) on 15-NOV-2007, and the third dose (lot number 660387/1967U) on 27-MAY-2008. In spring 2008, the patient wanted to opthamologist as could not see at school, bilat, dead spots seen on each optic nerve. Patient had had a normal eye exam in 2005. In 2008, the 11 year old patient experienced optic neuritis after GARDASIL 1 to 3 dose. At the time of this report, the patient''s adverse events did not recover. The patient''s "could not see at school" and bilat, dead spots seen on each optic nerve were considered to be disabling and other important medical events by the physician. Additional information has been requested.
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